Our ongoing efforts to strive to provide people in all countries with high quality products often sets Mylan apart. Key among these efforts are investing in innovation, expanding patient access and addressing unmet needs.
Innovation has fueled Mylan’s success for nearly 60 years and will continue to do so well into the future. More than 3,000 members of our workforce are dedicated to research and development, clinical, medical and regulatory professions. We have two global R&D centers, in the U.S. and India, and 10 technology-focused R&D sites across the U.S., India, Japan and Europe. From 2013-2017, Mylan invested more than $3 billion in cumulative R&D spend.1
Diverse Product Portfolio
In 2017 we continued our extension into new geographies such as China, Russia, Turkey, Mexico, Brazil and countries in Southeast Asia and the Middle East. We also enhanced our position as a provider of OTC medicines. Further, we have more than 1,000 projects in our product pipeline across our regions.
Over the past few years, Mylan has organized its products and services into 10 major therapeutic areas, helping us to better focus on patients’ needs by providing prescription generic, branded generic and brand-name drugs and OTC remedies where they are needed most. This structure helps us look at healthcare holistically and challenges us to provide access throughout patients’ lives.
Making Biologic Treatments More Affordable
Many biologics represent the cutting edge of medical science and have become the standard of care for various devastating and debilitating diseases such as cancer, autoimmune diseases and rare genetic disorders. A biosimilar is a product that is highly similar to and has no clinically meaningful differences from an existing approved biologic product. These products have helped to make biological treatments more affordable. Mylan has one of the most comprehensive and diverse programs in the industry, with 20 biosimilar and insulin analog products on the market or in our pipeline.
Maintaining Quality in Everything We Do
Because patients’ health and well-being are at stake, ensuring quality is essential for the pharmaceutical industry. Mylan has a global policy on Product Safety and robust global pharmacovigilance (PV) programs throughout products’ complete life cycle in an effort to prevent harm. Through our global PV system, we monitor Mylan’s products.
Our manufacturing facilities are routinely inspected by various health authorities around the world. For us, quality begins with product development, as we work to ensure an acceptable safety and efficacy profile for every drug we hope to market, and it extends through every step of the production process, from making or sourcing raw materials to producing finished dosage forms. Externally we work with health authorities to help develop standards that reflect the requirements needed to develop and manufacture products. We then work hard to ensure that our sites, and those of third parties we rely on, comply with them. Safety always is a priority in clinical trials, and we are committed to the highest standards and integrity. Mylan abides by the principles of good clinical practice (GCP), as defined in the Declaration of Helsinki and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) framework and implemented in international laws, directives and regulations. We also comply with applicable clinical-trial data-disclosure laws and regulations.
Blog featuring comments from Heather Bresch, Rajiv Malik and Anil Soni
1Cumulative spend refers to adjusted R&D. Adjusted metrics are non-GAAP financial measures. Please see appendix or investor.Mylan.com for the most directly comparable U.S. GAAP financial measures as well as reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measure.
2Product pipeline is molecule plus form, independent of market. Data as of March 1, 2018.
3Products pending approval is molecule plus form plus country. Data as of March 1, 2018.